The safety of Protopic (tacrolimus ointment) for the long-term intermittent treatment of children and adults with atopic dermatitis, more commonly known as eczema, was validated and the data were presented at the 61st Annual Meeting of the American Academy of Dermatology in San Francisco.

"These studies evaluated the risk of adverse events over time and most importantly found no indication that Protopic has long-term immunosuppressive effects in patients," said John Koo, Professor and Vice Chairman, Department of Dermatology, University of California-San Francisco, Director of Dermatology Drug Research Unit and Director of Psoriasis and Skin Treatment Center and Phototherapy Unit, who presented the data. "Furthermore, patients rarely discontinued treatment due to an adverse event including a burning sensation or lack of efficacy," added Dr. Koo.

Tacrolimus ointment is the first in a new class of prescription drugs called topical immunomodulators, or TIMs, to be developed in more than 40 years for the treatment of eczema. The FDA approved the non-steroidal alternative in December 2000 for short-term and intermittent long-term therapy to treat the signs and symptoms of moderate to severe eczema in patients for whom conventional treatments are deemed inadvisable because of the potential risks associated with them, or in patients who are not adequately responsive to or intolerant of conventional therapies.

The open label, non-comparative, multi-center study included 7,341 adult and pediatric patients with mild to severe atopic dermatitis. Half of the patients were children two to 15 years of age. Patients in the study applied Protopic 0.1 percent concentration ointment twice daily to all affected areas of the skin until one week after symptoms cleared. Patients participated in the study for a mean duration of up to two years. The majority of patients received tacrolimus ointment as monotherapy during the study.

In a separate open label, multi-center study of adult and pediatric patients, 799 patients received at least one dose of Protopic 0.1 per cent concentration ointment and were followed for a median duration of 33 months with 300 patients participating in the study for more than three years. Nearly half of the patients were children.

Conventional therapies for eczema have been limited and variable outcomes have been reported. Routine treatment frequently includes the use of steroid creams applied to the skin. Steroids have been associated with side effects including skin thinning, stretch marks and skin discoloration. Physician and patient satisfaction has been disappointing.

Protopic is available in two concentrations for adults, 0.03 per cent and 0.1 per cent. For children ages two to 15, only the 0.03 percent concentration is indicated. There may be an increased risk of certain types of skin infections for patients using Protopic. In addition, patients should avoid direct exposure to natural or artificial sunlight and should not cover treated skin with bandages, dressings or wraps.